Effects of Chantix on Relapse Prevention for Smoking Cessation

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The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

Condition or disease

Intervention/treatment

Phase

Nicotine Dependence

Drug: PlaceboDrug: Varenicline

Phase 4

Detailed Description:

The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. Specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. In addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.

Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).

Drug: Varenicline

Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily

Other Name: Chantix

Placebo Comparator: Placebo

Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).

Drug: Placebo

Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion Criteria:

Smoking Behavior

Use of chewing tobacco or snuff

Current enrollment or plans to enroll in another smoking cessation program in the next 5 months

Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months